Regulatory Affairs Pharmacist Expert
5 days ago
The Regulatory Affairs Pharmacist will be responsible for managing work streams and reporting on assigned portfolios of products. This includes assisting with internal and external product queries, establishing regulatory priorities, and allocating resources and workloads.
Key Responsibilities
- Manage work streams for- and report on the assigned portfolio of products:
- Assist with internal product queries from relevant departments:
- Assist with external product queries from regulatory authorities and third-party stakeholders:
- Establish regulatory priorities and allocate resources and workloads:
- Review regulatory agency submissions to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards:
- Coordinate and submit new product applications in South Africa and other applicable territories:
- Develop regulatory strategies and implementation plans for the preparation and submission of new products:
- Conduct dossier due diligence to ensure all data gaps are addressed:
- Prepare registration applications for submission to regulatory authorities:
- Work with internal and external stakeholders to assess regulators' submissions requirements:
- Maintain existing registrations in accordance with relevant legislation, regulations, and guidelines:
Required Skills and Qualifications
- Bachelor's degree in Pharmacy or Diploma in Pharmacy and registration with the South African Pharmacy Council:
- 3 to 5 years of experience in Regulatory Affairs, preferably in human medicines:
- Demonstrable experience across the product development, commercialization, and maintenance lifecycle:
- Sound project management capabilities:
- Proven ability to consistently deliver to quality, time, and cost standards:
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Midrand, Gauteng, South Africa XCaliber Staffing Full timeIntroductionOur client has a track record of nearly 3 decades in the medical industry They are a leading South African based distributor of high-quality medical consumables and equipment, working with professionals in both private practice and state health facilities.They are looking for their next superstar Regulatory Responsible PharmacistDuties &...
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